Last Updated: July 27, 2026

Suppliers and packagers for ZYRTEC ALLERGY


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ZYRTEC ALLERGY

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Kenvue Brands ZYRTEC ALLERGY cetirizine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 022578 NDA Kenvue Brands LLC 50580-778-24 4 BLISTER PACK in 1 CARTON (50580-778-24) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 2014-01-20
Kenvue Brands ZYRTEC ALLERGY cetirizine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 022578 NDA Kenvue Brands LLC 50580-782-01 2 CARTON in 1 PACKAGE (50580-782-01) / 4 BLISTER PACK in 1 CARTON / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 2014-01-20
Kenvue Brands ZYRTEC ALLERGY cetirizine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 022578 NDA Kenvue Brands LLC 50580-782-12 2 BLISTER PACK in 1 CARTON (50580-782-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 2014-01-20
Kenvue Brands ZYRTEC ALLERGY cetirizine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 022578 NDA Kenvue Brands LLC 50580-782-24 4 BLISTER PACK in 1 CARTON (50580-782-24) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 2014-01-20
Kenvue Brands ZYRTEC ALLERGY cetirizine hydrochloride TABLET;ORAL 019835 NDA JC World Bell Wholesale Co., Inc. 50269-014-01 6 BLISTER PACK in 1 BOX (50269-014-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK 2019-01-20
Kenvue Brands ZYRTEC ALLERGY cetirizine hydrochloride TABLET;ORAL 019835 NDA JC World Bell Wholesale Co., Inc. 50269-019-02 6 BLISTER PACK in 1 BOX (50269-019-02) / 2 TABLET, FILM COATED in 1 BLISTER PACK 2019-01-20
Kenvue Brands ZYRTEC ALLERGY cetirizine hydrochloride TABLET;ORAL 019835 NDA JC World Bell Wholesale Co., Inc 50269-973-01 20 POUCH in 1 BOX (50269-973-01) / 1 TABLET, FILM COATED in 1 POUCH 2018-07-27
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for ZYRTEC ALLERGY

Last updated: May 29, 2026

ZYRTEC Allergy Suppliers: Who Manufactures Cetirizine, API Sources, and Contract Manufacturing Channels

Executive summary: Zyrtec Allergy is a brand of cetirizine (antihistamine). Supplier identification depends on whether the product is U.S. OTC “ZYRTEC” (typically distributed under McNeil Consumer Healthcare, a Johnson & Johnson affiliate) and which dosage form is in scope (tablet vs liquid vs chewable/gummies). High-confidence supplier mapping requires Orange Book/NDC-linked label and packaging-batch data, which is not provided here. With only the generic product name, supplier coverage cannot be made complete and accurate.

If you provide a specific NDC (or dosage form and strength, e.g., “ZYRTEC 10 mg tablets” vs “ZYRTEC Liquid 1 mg/mL”), supplier lists can be built from labeler-of-record, distributor, and manufacturer/packer strings and matched to API and finished-dose manufacturing networks.

Who supplies Zyrtec Allergy in the US: manufacturer, packer, and labeler-of-record?

Featured snippet answer: Zyrtec Allergy is supplied as a finished dosage by the product’s labeler-of-record on the U.S. OTC drug listing for the specific dosage form and strength. The labeler-of-record is the most reliable “supplier” identifier for regulatory and commercial diligence because it governs distribution and OTC compliance obligations.

What “supplier” means for OTC Zyrtec diligence

For Zyrtec Allergy, due diligence commonly needs three supplier layers:

  1. Finished-dose manufacturer/packer (site that makes or packages the marketed form)
  2. Labeler/distributor (entity on the OTC listing that owns product compliance)
  3. API source for cetirizine (often multiple qualified suppliers; may include direct API and intermediates)

Without the exact NDC, the finished-dose manufacturer and packer cannot be mapped.

Which companies supply cetirizine API used in Zyrtec Allergy?

Featured snippet answer: Cetirizine API is supplied through a multi-source global API market. For Zyrtec specifically, the API supplier list is determined by cGMP drug master file referencing, supplier qualification, and label/CMC disclosures, which are not specified for the brand in the prompt.

Common cetirizine API supply patterns

Finished-dose brands typically qualify multiple API sources and lock purchasing to:

  • DMF-referenced API or controlled supplier agreements
  • Quality agreements tied to finished-dose specifications
  • Regional supply continuity to manage attrition and regulatory risk

A credible API supplier map needs NDC-linked product details or CMC disclosures tied to the product.

What dosage forms of Zyrtec Allergy have different manufacturing suppliers?

Featured snippet answer: Zyrtec Allergy manufacturing suppliers can differ across tablets, chewables, and liquid due to differences in:

  • granulation and coating systems
  • liquid manufacturing and filling lines
  • flavoring/sweetener and viscosity systems
  • packaging formats (blister, bottle, unit-dose)

Dose-form split that drives supplier changes

  • 10 mg tablets often run on tablet presses and coating lines
  • liquids (1 mg/mL) require solution/suspension preparation, filtration, and bottling/filling
  • chewables/gummies require shaping, coating, or encapsulation workflows

Without a specified dosage form, supplier identification will be incomplete.

How do you identify Zyrtec Allergy suppliers using NDC and labeler information?

Featured snippet answer: Use the NDC directory record for the exact strength and dosage form. The record lists:

  • labeler
  • manufacturer/packer
  • sometimes the distributor

This is the fastest method to build a defensible “supplier” list for procurement, licensing, or litigation-style due diligence.

What documents are typically used in diligence

  • FDA OTC labeling data tied to the product NDC
  • Packaging insert and carton labeling manufacturer strings
  • Regulatory correspondence and CMC references (where available)

No NDC is included in the prompt, so a precise supplier list cannot be produced.

What finished-dose contract manufacturing suppliers could make cetirizine for Zyrtec?

Featured snippet answer: Cetirizine finished doses are commonly made via either:

  • internal manufacturing networks of the brand holder or affiliate, or
  • contract manufacturing partners that run OTC antihistamine workflows

However, listing specific contract manufacturers for Zyrtec requires the finished-dose manufacturer/packer text from the labeled product or NDC record.

How many suppliers typically support cetirizine finished dose supply?

Featured snippet answer: Most established antihistamine brands maintain multiple supplier lanes to reduce stockout risk and manage change control. The number of qualified finished-dose sites varies by:

  • market volume
  • packaging configuration complexity
  • quality and regulatory history
  • site capacity constraints

A numeric supplier count for Zyrtec requires NDC-level manufacturer/packer extraction.

What quality and compliance constraints shape Zyrtec supplier selection?

Featured snippet answer: Supplier selection for OTC cetirizine products is constrained by:

  • cGMP compliance for both API and finished dose
  • validated cleaning, segregation, and contamination controls
  • stability and shelf-life capability tied to the dosage form
  • packaging system compatibility

These requirements narrow the supplier list, but they do not identify which specific firms supply Zyrtec without product-linked label data.


Key Takeaways

  • Zyrtec Allergy is cetirizine; “suppliers” for diligence must be defined as finished-dose manufacturer/packer and labeler-of-record for the specific dosage form and NDC.
  • The prompt does not include NDC, dosage form, or strength, so a complete and accurate supplier list cannot be produced.
  • API supplier identification for cetirizine requires CMC/DMD referencing or product-linked quality documentation tied to the specific marketed form.

FAQs

  1. How can I identify the manufacturer of Zyrtec Allergy for a specific product strength?
    Use the product’s NDC and read the manufacturer/packer and labeler-of-record fields from FDA’s NDC/OTC listing records.

  2. Do Zyrtec liquid and Zyrtec tablets come from the same manufacturing site?
    Often not. Tablets and liquids use different manufacturing and filling systems, so sites can differ by dosage form.

  3. Who supplies cetirizine API to branded antihistamine products in general?
    Cetirizine API is multi-sourced globally; branded usage depends on qualified supplier lists referenced in CMC documentation.

  4. Can contract manufacturers produce Zyrtec under private label?
    Yes, OTC supply can include contract manufacturing, but identifying the contract firm requires manufacturer/packer text tied to the labeled NDC.

  5. What is the fastest method for building a defensible Zyrtec supplier map for procurement or licensing?
    Extract manufacturer/packer and labeler from the exact NDC product record, then map to known API/CMC sourcing through referenced filings and supplier qualification records.


References

No sources were cited because no NDC, dosage form, strength, or labeler/manufacturer strings were provided in the prompt.

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